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PD-L1 Inhibitor
Olaparib + Durvalumab for Solid Tumors (SOLID Trial)
Phase 2
Recruiting
Led By Eric Chen, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Cohort A: Patients must have histologically or cytologically confirmed diffuse astrocytic and oligodendroglial tumors by World Health Organization 2016 classification which are IDH mutant. They must have not received more than 2 regimens of systemic therapy after initial relapse.
Must be ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
SOLID Trial Summary
This trial will test the effectiveness of a new combination of drugs to treat patients with IDH-mutated solid tumors.
Who is the study for?
Adults with IDH-mutated solid tumors, including specific brain and bile duct cancers, who have undergone limited prior treatments can join this trial. They must be in good physical condition (ECOG 0-1), not pregnant, willing to prevent pregnancy, and able to swallow pills. Participants should have a life expectancy of at least 16 weeks and stable health without recent major surgeries or uncontrolled medical issues.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Olaparib and Durvalumab for treating IDH-mutated solid tumors. The goal is to see if taking these drugs together works better than when they're taken separately by measuring how well the cancer responds and how long patients' diseases are controlled.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could cause inflammation in various organs, fatigue, nausea, blood cell count changes which might increase infection risk or bleeding tendencies. There may also be allergic reactions related to either drug.
SOLID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor is IDH mutant and I've had no more than 2 treatments after it first came back.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have IDH mutant adenocarcinoma of the biliary tract and have had 2 or fewer treatments for advanced disease.
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My brain tumor is IDH mutant and I've had no more than 2 treatments after it first came back.
Select...
I am willing and able to follow the study's treatment and visit schedule.
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My body weight is over 30 kg.
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My disease can be measured or tracked.
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I have IDH mutant adenocarcinoma of the biliary tract and have had 2 or fewer treatments for advanced disease.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
SOLID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall disease control rate
Overall response rate
Secondary outcome measures
Number of incidences of adverse events
Overall survival
Progression-free survival
SOLID Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: IDH mutated cholangiocarcinomaExperimental Treatment2 Interventions
Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
Group II: Cohort A: IDH mutated gliomaExperimental Treatment2 Interventions
Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2210
Durvalumab
2017
Completed Phase 2
~3840
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,484 Previous Clinical Trials
489,359 Total Patients Enrolled
Eric Chen, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious, uncontrolled health issues or infections.My brain tumor is IDH mutant and I've had no more than 2 treatments after it first came back.I have lasting side effects from cancer treatment, but not hair loss or blood test issues.I am 18 years old or older.I have a brain tumor or cancer spread to the brain, feel fine, and it's been 4 weeks since my last brain treatment.I am fully active or can carry out light work.I cannot swallow pills or have stomach issues affecting medication absorption.I have IDH mutant adenocarcinoma of the biliary tract and have had 2 or fewer treatments for advanced disease.I have a brain tumor or cancer spread to the brain, feel fine, and it's been 4 weeks since my last brain treatment.I am not currently using, or have stopped using certain strong medications that affect how other drugs work, for the required time before starting treatment.I had major surgery over 2 weeks ago and have recovered from it.My brain tumor is IDH mutant and I've had no more than 2 treatments after it first came back.I have received an organ transplant from another person.I haven't had cancer treatment in the last 4 weeks.I have not needed a blood transfusion in the last 4 months.I am willing and able to follow the study's treatment and visit schedule.My organ and bone marrow functions are normal as tested within the last 28 days.I have had an autoimmune or inflammatory disorder in the past 2 years.My body weight is over 30 kg.My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have brain metastases that are not under control and cause symptoms.I do not have any active infections, including tuberculosis.I have never been treated with PARP or PD-1/PD-L1 inhibitors like olaparib or durvalumab.I am not pregnant, breastfeeding, nor plan to become pregnant during the study.I haven't had any other cancer in the last 5 years.I haven't had chemotherapy or radiotherapy (except for comfort care) in the last 4 weeks.I have active hepatitis B or C.My disease can be measured or tracked.I have IDH mutant adenocarcinoma of the biliary tract and have had 2 or fewer treatments for advanced disease.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I have not received live vaccines within 30 days before or will not during the study.I am 18 years old or older.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: IDH mutated glioma
- Group 2: Cohort B: IDH mutated cholangiocarcinoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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